Randomized Double Blind Placebo Controlled Trial of the Steroid Sparing Effect of Xolair (Omalizumab) in Patients With Persistent Eosinophilic Bronchitis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 5
- 主要终点
- Magnitude of the reduction in the dose of corticosteroid from week 12 to week 32.
研究概览
简要总结
The purpose of this study is to investigate whether addition of Omalizumab enables a reduction in the dose of prednisone in patients with asthma and eosinophilic bronchitis.
This will be a double-blind placebo-controlled, 3-centre, randomized parallel group trial divided into two sequential study periods.
Period 1: After establishing the minimum dose of prednisone to maintain asthma control and maintain sputum eosinophils <3%, subjects will be randomized to either placebo or Omalizumab for 16 weeks (either once monthly for 4 months or every 2 weeks for 4 months).
Period 2: standardised prednisone reduction at intervals of 4-weeks until there is a clinical and eosinophilic exacerbation or bothersome steroid withdrawal effects. If patients have an exacerbation, they will be treated with prednisone. This patient will continue on Omalizumab or placebo during the entire duration of the study but not continue the phase of steroid reduction.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Omalizumab (Xolair)
Dosage/frequency is dependent on body weight (kg) and baseline blood IgE level.
干预措施: Placebo (Drug)
Placebo (Normal Saline)
0.9% normal saline equivalent to the dosage/frequency/duration of Omalizumab
干预措施: Omalizumab (Xolair) (Biological)
结局指标
主要结局
Magnitude of the reduction in the dose of corticosteroid from week 12 to week 32.
时间窗: From Week 12 to Week 32
Proportion of patients with change in absolute % count of sputum eosinophil week 0 to week 12, and week 12 to week 32
时间窗: From Week 0 to Week 12 and Week 12 to week 32
次要结局
- Blood eosinophils(From Week 0 to week 32)
- Forced Expired Volume in 1 second (FEV1)(From Week 0 to Week 32)
- Fraction of exhaled nitric oxide (FeNO)(From Week 0 to Week 32)
- Asthma Control Questionnaire(From Week 0 to Week 32)
- Ratio of Forced Expired Volume in 1 second to Forced Vital Capacity (FEV1/VC)(From Week 0 to Week 32)
- Provocative concentration causing a 20% drop in FEV1 (PC20)(From Week 0 to Week 32)
- change in % sputum eosinophil(From Week 0 to Week 32)